The effects of nutritional supplements on postprandial nitric oxide bioactivity in abdominally obese me
- Conditions
- Insulin Resistance SyndromeSyndrome X10013317Metabolic Syndrome
- Registration Number
- NL-OMON46749
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
- Men
- Aged between 40-70 years
- Waist circumference >= 102
- Fasting plasma glucose < 7.0 mmol/L
- Fasting serum total cholesterol < 8.0 mmol/L
- Stable body weight (weight gain or loss < 3 kg in the past three months)
- Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
- No difficult venipuncture as evidenced during the screening visit
- No current smoker
- No diabetic patients
- No familial hypercholesterolemia
- No abuse of drugs
- No more than 3 alcoholic consumptions per day
- No use of medication known to treat blood pressure, lipid or glucose metabolism
- No use of an investigational product within another biomedical intervention trial within the previous 1-month
- No intolerance or allergy to the ingredients of the intervention products (e.g. lactose or gluten)
- No severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
- No active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- Willingness to give up the use of antibacterial mouth wash or antibacterial toothpaste, chewing-gum and tongue-scraping on the morning of each experimental test day
- Women
- Fasting plasma glucose >= 7.0 mmol/L
- Fasting serum total cholesterol >= 8.0 mmol/L
- Current smoker, or smoking cessation <12 months
- Diabetic patients
- Familial hypercholesterolemia
- Abuse of drugs
- More than 3 alcoholic consumptions per day
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- Use medication known to treat blood pressure, lipid or glucose metabolism
- Use of an investigational product within another biomedical intervention trial within the previous 1-month
- Intolerance or allergy to the intervention products (e.g. lactose or gluten)
- Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
- Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- Not willing to give up being a blood donor from 8 weeks before the start of the study, during the study or for 4 weeks after completion of the study
- Not or difficult to venipuncture as evidenced during the screening visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Measurements will be performed before and two hours after consumption of the<br /><br>high fat milkshake and the five interventional products. The primary endpoint<br /><br>is the difference in postprandial change in FMD between the five interventional<br /><br>products. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are the postprandial effects of the interventional products<br /><br>on retinal microvascular function, plasma cGMP (as indicator of nitric oxide<br /><br>bioactivity), plasma markers for low-grade systemic inflammation and<br /><br>endothelial dysfunction, blood pressure, and serum lipid and plasma glucose<br /><br>metabolism.</p><br>